{"id":5921,"date":"2019-09-09T15:11:14","date_gmt":"2019-09-09T09:41:14","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=5921"},"modified":"2025-05-08T11:46:43","modified_gmt":"2025-05-08T06:16:43","slug":"systemic-sclerosis-treatment","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/systemic-sclerosis-treatment","title":{"rendered":"FDA approves Ofev  for interstitial lung disease"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-white ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-69f2c601a3771\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-69f2c601a3771\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.delveinsight.com\/blog\/systemic-sclerosis-treatment\/#Systemic_sclerosis\" >Systemic sclerosis<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.delveinsight.com\/blog\/systemic-sclerosis-treatment\/#Estimating_Systemic_sclerosis_Epidemiology_is_difficult\" >Estimating Systemic sclerosis Epidemiology is difficult<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.delveinsight.com\/blog\/systemic-sclerosis-treatment\/#No_standard_Systemic_sclerosis_Therapy_so_far\" >No standard Systemic sclerosis Therapy so far<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.delveinsight.com\/blog\/systemic-sclerosis-treatment\/#Systemic_sclerosis_Upcoming_Therapies\" >Systemic sclerosis Upcoming Therapies<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.delveinsight.com\/blog\/systemic-sclerosis-treatment\/#Companies_working_to_advance_Systemic_sclerosis_Therapy_market\" >Companies working to advance Systemic sclerosis Therapy market<\/a><\/li><\/ul><\/nav><\/div>\n\n<p class=\"has-drop-cap\">Recently, the US FDA has approved a new drug therapy to treat adults with interstitial lung disease associated with systemic sclerosis or scleroderma, called SSc-ILD. <br><strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/ofev-api-insights\">Ofev (nintedanib)<\/a><\/strong> capsules, the drug developed by Boehringer Ingelheim Pharmaceuticals, has shown efficacy in slowing down the rate of decline in pulmonary function in systemic sclerosis patient pool. <\/p>\n\n\n\n<p>Most of the systemic sclerosis patients\nsuffer fatal death because of the loss of pulmonary function due to the lack of\nenough oxygen to the heart. <\/p>\n\n\n\n<p><strong>Ofev <\/strong>is an oral triple angiokinase inhibitor, which simultaneously inhibits vascular endothelial growth factor receptors (VEGFR 1-3), platelet-derived growth factor receptors (PDGFR), and fibroblast growth factor receptors (FGFR 1-3) signalling pathways. <\/p>\n\n\n\n<p>These three different angiokinase\nreceptors are not yet targeted simultaneously by any currently available\ntherapies. The therapeutic candidate has been allotted Orphan Drug Designations\nfrom both FDA and EMA for the treatment of systemic sclerosis-associated\ninterstitial lung disease (SSc-ILD). FDA has also granted Fast Track designation\nto Ofev for the treatment of SSc-ILD.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Systemic_sclerosis\"><\/span><strong>Systemic sclerosis <\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>Systemic sclerosis or scleroderma\n(SSc) is a rare autoimmune disorder that affects connective tissues of the skin\nand internal organs. <\/p>\n\n\n\n<p>The most prominent and noticeable symptom of the condition is a buildup of the scar tissues due to the excess collagen leading to hardening of the skin. As a consequence, the normal functioning of the skin, joints, tendons, ligaments, and internal organs gets hampered. <\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Estimating_Systemic_sclerosis_Epidemiology_is_difficult\"><\/span><strong>Estimating Systemic sclerosis Epidemiology is difficult<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>Systemic sclerosis Epidemiology\nestimation is not easy to calculate owing to the rarity of the disease and its\nquality to exhibit wide range of symptoms. <\/p>\n\n\n\n<p><strong>Systemic sclerosis is rare in children<\/strong>, however, can be noticed in people aged 20 to 50. This could be due to the fact that the symptoms begin to appear during midlife. <\/p>\n\n\n\n<p>Systemic sclerosis prevalence is about\nfour times more common in women than men. This is backed by a study led by Schwartz\n2018, which observed that systemic sclerosis usually appears in women aged\n30\u201340 years, and in slightly older men. <\/p>\n\n\n\n<p>In approximately 85% of cases,\nsystemic sclerosis develops in individuals aged 20\u201360 years.<\/p>\n\n\n\n<p class=\"has-background has-cyan-bluish-gray-background-color\">As per the National Organization for Rare Disorders, systemic scleroderma is estimated to affect 40,000\u2013165,000 people in the US.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"No_standard_Systemic_sclerosis_Therapy_so_far\"><\/span><strong>No standard Systemic sclerosis Therapy so far<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>Systemic sclerosis  is far more than just any inflammatory <br>There is no standard Systemic sclerosis treatment that effectively modifies the overall disease course. <br>The therapies present target specific organs and work to prevent irreversible damage to improve the quality of life and survival rate. <\/p>\n\n\n\n<p>The Systemic sclerosis therapeutics market size is dominated by supportive therapies and current therapies and medications that focus on the four main features of the disease: inflammation, autoimmunity, vascular disease, and tissue fibrosis. <\/p>\n\n\n\n<p>Currently, <strong>immunosuppressive agents <\/strong>such as methotrexate, cyclophosphamide, mycophenolate mofetil, Azathioprine, autologous stem cell transplantation, and others are therapeutic choices.<\/p>\n\n\n\n<p>There are a number of <strong>Systemic sclerosis treatments<\/strong>, however, they have many limitations. Most of the therapies have some adverse effects and there is no single accepted medical Systemic sclerosis treatment for aggressive fibromatosis.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Systemic_sclerosis_Upcoming_Therapies\"><\/span><strong>Systemic sclerosis Upcoming Therapies<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>Potential novel <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/systemic-scleroderma-market\">Systemic Sclerosis therapies<\/a><\/strong> are under development to improve the therapy landscape. Therapies such as monoclonal antibodies, cell-based therapies, and other novel molecules are in the pipeline stage of development.<\/p>\n\n\n\n<p>For decades, clinical and\nmolecular research focused on understanding the primary process of fibrosis.\nMore recently, the inflammatory, immunological, and vascular components that\nprecede the actual onset of fibrosis have become a matter of increasing\nscientific scrutiny.<\/p>\n\n\n\n<p><strong>Lenabasum<\/strong> (Corbus Pharmaceuticals), <strong>Tocilizumab <\/strong>(Roche), <strong>GLPG1690 <\/strong>(Galapagos NV) and <strong>FCX-013<\/strong> (Fibrocell) are some of the Systemic Sclerosis upcoming therapies. <\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Companies_working_to_advance_Systemic_sclerosis_Therapy_market\"><\/span><strong>Companies working to advance Systemic sclerosis Therapy market <\/strong><span class=\"ez-toc-section-end\"><\/span><\/h4>\n\n\n\n<p>Major healthcare players, such as <strong>Corbus Pharmaceuticals<\/strong>, <strong>Boehringer Ingelheim<\/strong>, <strong>Roche<\/strong>, <strong>Kaken Pharmaceutical<\/strong>, <strong>GlaxoSmithKline<\/strong>, <strong>Novartis<\/strong>, <strong>Genentech<\/strong>, <strong>Galapagos NV<\/strong>, and <strong>Fibrocell<\/strong>, are involved in the development of therapies for the Systemic Sclerosis treatment.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Recently, the US FDA has approved a new drug therapy to treat adults with interstitial lung disease associated with systemic sclerosis or scleroderma, called SSc-ILD. Ofev (nintedanib) capsules, the drug developed by Boehringer Ingelheim Pharmaceuticals, has shown efficacy in slowing down the rate of decline in pulmonary function in systemic sclerosis patient pool. Most of [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":5927,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[17],"tags":[17289,17772,704,17775,17774,1135,985,17773,423,17771,524,6057,6058],"industry":[17225],"therapeutic_areas":[17242],"class_list":["post-5921","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles","tag-boehringer-ingelheim","tag-corbus-pharmaceuticals","tag-fda","tag-fibrocell","tag-galapagos-nv","tag-genentech","tag-glaxosmithkline","tag-kaken-pharmaceutical","tag-novartis","tag-ofev","tag-roche","tag-scleroderma","tag-systemic-sclerosis","industry-pharmaceutical","therapeutic_areas-cardiovascular-diseases"],"acf":[],"yoast_head":"<!-- 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href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Articles<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Articles<\/span>"]},"tags":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Boehringer Ingelheim<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Corbus Pharmaceuticals<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">FDA<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Fibrocell<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Galapagos NV<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Genentech<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">GlaxoSmithKline<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Kaken Pharmaceutical<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Novartis<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Ofev<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Roche<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">scleroderma<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">systemic sclerosis<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Boehringer Ingelheim<\/span>","<span class=\"advgb-post-tax-term\">Corbus Pharmaceuticals<\/span>","<span class=\"advgb-post-tax-term\">FDA<\/span>","<span class=\"advgb-post-tax-term\">Fibrocell<\/span>","<span class=\"advgb-post-tax-term\">Galapagos NV<\/span>","<span class=\"advgb-post-tax-term\">Genentech<\/span>","<span class=\"advgb-post-tax-term\">GlaxoSmithKline<\/span>","<span class=\"advgb-post-tax-term\">Kaken Pharmaceutical<\/span>","<span class=\"advgb-post-tax-term\">Novartis<\/span>","<span class=\"advgb-post-tax-term\">Ofev<\/span>","<span class=\"advgb-post-tax-term\">Roche<\/span>","<span class=\"advgb-post-tax-term\">scleroderma<\/span>","<span class=\"advgb-post-tax-term\">systemic sclerosis<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 7 years ago","modified":"Updated 12 months ago"},"absolute_dates":{"created":"Posted on Sep 9, 2019","modified":"Updated on May 8, 2025"},"absolute_dates_time":{"created":"Posted on Sep 9, 2019 3:11 pm","modified":"Updated on May 8, 2025 11:46 am"},"featured_img_caption":"Systemic 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